A. Sample submission requirements:
I. Essential Documents:
a. Forwarding Letter from Drug Regulatory Authority
or any other statutory authority of the country which has been marked to NIB
for testing/evaluation purpose.
of Import License/Test License issued by Govt. of India
i. Form -11 (Copy of Import License for
ii. Form -10 (Copy of Import License for
iii. Form MD-15 (Copy of License to Import Medical Device)
iv. Form MD-17 (License to Import Medical Devices for the purpose of Evaluation)
v. Form MD-13 (License to Manufacture Medical Devices for the purpose of Testing)
of Manufacturing License Issued by Govt. of India (In case of Indigenous
Product) Form 25/28/29
of Analysis from Manufacturer in respect of the lot submitted for evaluation.
Release Certificate (BRC) from Manufacturer/NCA/NCL of the Country of origin
for the lot submitted for evaluation.
insert and label Claim of the Product
Product Specific requirements:
Products Lab- Plasma Based products:
Release from the country of origin for imported samples
of analysis with name of pharmacopoeia complied
kit lab (Glucose strips)
of Sample: Blood Glucose Test strips designed for use with specific Glucometers
as a closed system that reports the human blood glucose values in mg/dL units.
of Packing: Blood Glucose Test Strips should be packed in properly labelled
sealed containers that give the details of the manufacturer and/ or the
importer and the Range of values reported by the strips for the Norma (Level
I) and the Pathological (Level II) Control preparations.
3. Number of Samples Essential: 2400 Test Strips
(1200 for the laboratory and 1200 as retained samples with the Sample Receipt
unit) for testing one Batch by the Laboratory.
Required: 10 Glucometers designated for use with the Blood Glucose Test Strips
as a closed system.
x 3 vials each of the manufacturers Normal/ Level I and Pathological/ Level II
Glucose control Solution for testing one batch of Blood Glucose Test Strips.
Testing fee requirements:
Testing Fee Details
1. FOR PAYMENT/DEPOSIT
OF TESTING FEE THOUGH BANK TRANSFER
OF BANK : BANK OF BARODA, SECTOR-29, NOIDA
OF ACCOUNT : NATIONAL INSTITUTE OF BIOLOGICALS
ACCOUNT : 26290100001774
CODE : BARB0NOIDAX
CODE : 2BARBINBBNOI
CODE NO. : 110012066
2. Net banking : http://www.nib.gov.in/testing_fee.html
FEES IS REQUIRED TO BE SUBMITTED IN ADVANCE ALONG WITH THE RESPECTIVE BATCH
SENT TO THE INSTITUTE FOR TESTING
Fees once submitted at NIB for Samples forwarded through Zonal / Sub-zonal/
Port Offices of CDSCO which can be tested at NIB cannot be refunded.
Fees submitted at NIB for Samples which cannot be tested at NIB can be refunded
or adjusted against other samples within a month of submission of testing fee.
Fees submitted Online should also be intimated to the Institute through email
(1) email@example.com (2) firstname.lastname@example.org
C. Sample forwarded under the Drugs & Cosmetics Act:
Govt. Analysts under schedule C1 as per the Gazette notification are notified
for the below mention class of drugs.
D. Documentation and Archiving:
documents and records are kept in compliance to ISO: 17025.
E.Complete Unit is under CCTV Surveillance
for necessary security and maintenance of samples and records.
F.Customer feedback is
always acknowledged. Submission of feedback should be marked at email@example.com. Further a
Suggestions / Complaints / Feedback Register has also being placed in the Unit for necessary redressal.